Howmedica Osteonics Corp.: The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an

Hazard

When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

Details from the source

Reason for recall: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea. Quantity: 320 units Lot/code info: Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

UPC codes

37613327097628

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.